Regulations

35 Results

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

High quality services in CDMO: Indena’s leadership in a strategic market

Indena | 16-Mar-2020 | Technical / White Paper

Contract manufacturers are required to heavily invest in building new facilities. Thanks to its strategic choices of investment moves and the adoption...

Make the move to PyroMAT™ System: the only cell line-based Monocyte Activation Test for the detection of pyrogens

Merck KGaA, Darmstadt, Germany | Recorded the 25-Oct-2018 | Webinar

For pharmaceutical companies, patient safety has always been the priority. That’s why pyrogen detection has become a mandatory Quality Control test for...

Enabling drug traceability. Implementing serialization in practice as a CDMO.

R-Pharm Germany GmbH | Recorded the 10-Oct-2017 | Webinar

R-Pharm Germany has established an effective track & trace system to meet all regulatory requirements and to offer cost-effective and customer-oriented...

FDA Focus̶ Product Design and Post Approval Changes

Colorcon Inc. | 19-Sep-2016 | Technical / White Paper

Review a new Colorcon Technical Paper offering a summary of key points presented in the recent US Center for Drug Evaluation and Research (CDER) Guidance...

Amino Acid Analysis of Pharmaceutical Products

SGS Life Science Services | 11-Jul-2016 | Technical / White Paper

Amino Acid Analysis in general can be used for identification testing of biopharmaceutical active ingredients and the determination of impurities and related...

Rapid Microbiological Method Statistics & Validation

EMD Millipore | Recorded the 17-May-2016 | Webinar

It is well known that implementation of Rapid Microbiological Methods in Pharma environments is accompanied by a large validation workload to ensure that...

Live Webinar on Recent PAT applications for Softgels presented by Softigel by Procaps

Procaps S.A. | Recorded the 30-Nov-2015 | Webinar

Process Analytical Technologies (PAT) in solid dosages forms are commonly used for tablets. Procaps brings to you this webinar intended to present PAT...

Article on Viral Clearance for Biopharmaceuticals

Catalent Pharma Solutions | 24-Aug-2015 | Technical / White Paper

Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals. These studies are a key component...